Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-14 @ 1:02 AM
Study NCT ID:
NCT02750527
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2016-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
Sponsor:
Kinderkrankenhaus auf der Bult
Organization:
Study Overview
Official Title:
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fr1dolin
Brief Summary:
This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6 years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9) routine check-ups and any voluntary visits to the pediatricians office.
Detailed Description:
The Fr1dolin-Study will be presented to the parents of ca. 320,000 children living in Lower Saxony, Germany. The recruitment of subjects, collection of written consent, the capillary blood sample and the screening questionnaire will be done by the registered pediatricians in their local medical practices.
After study enrolment 200 µl of capillary blood are be taken from the subject and are sent pseudo-anonymized to the lab. LDL-C and the diabetes-associated antibodies are identified. Based on the results a second blood sample will be required. In case of pre-type-1 diabetes or signs for a familial hypercholesterolemia the pediatrician will be informed. He will contact the parents and discuss the further procedure in cooperation with the study center.
In case of a positive result by measuring diabetes-related antibodies and LDL-C the goal of this trial is to advise and educate the families appropriate and to treat them if necessary. In addition families should have the possibility to participate in prevention trials.
All data will be registered in a study database.
Follow-up pre-type 1 diabetes:
During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years or up to 6 months after the clinical onset of type 1 diabetes.
Follow-up familial hypercholesterolemia:
During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years.
After study enrolment 200 µl of capillary blood are be taken from the subject and are sent pseudo-anonymized to the lab. LDL-C and the diabetes-associated antibodies are identified. Based on the results a second blood sample will be required. In case of pre-type-1 diabetes or signs for a familial hypercholesterolemia the pediatrician will be informed. He will contact the parents and discuss the further procedure in cooperation with the study center.
In case of a positive result by measuring diabetes-related antibodies and LDL-C the goal of this trial is to advise and educate the families appropriate and to treat them if necessary. In addition families should have the possibility to participate in prevention trials.
All data will be registered in a study database.
Follow-up pre-type 1 diabetes:
During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years or up to 6 months after the clinical onset of type 1 diabetes.
Follow-up familial hypercholesterolemia:
During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: